This phase II trial evaluates the impact of acupuncture in preventing chemotherapy-induced peripheral neuropathy (CIPN) in patients with stage I-III breast cancer patients without pre-existing neuropathy who are undergoing taxane-based chemotherapy. Taxane is a type of chemotherapy that can cause damage to the nerves in the hands and feet as a potential side effect. CIPN, a side effect of taxane chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet. There are currently no proven treatments to prevent chemotherapy-induced peripheral neuropathy. Acupuncture is a complementary therapy in which, thin, sterile disposable needles are inserted into various spots on the skin. Acupuncture may help relieve pain from peripheral neuropathy caused by chemotherapy and may improve the quality of life of patients with breast cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT05528263.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To determine the impact of an acupuncture intervention (version [vs] relaxation exercise control) on the severity of chemotherapy-induced peripheral neuropathy (CIPN) symptoms in women receiving taxane-based chemotherapy for stage I-III breast cancer.
SECONDARY OBJECTIVES:
I. To determine the impact of an acupuncture intervention (vs relaxation exercise control) in women receiving taxane-based chemotherapy for stage I-III breast cancer on:
Ia. Incidence of CIPN;
Ib. Relative dose intensity (RDI) of taxane treatment;
Ic. Maximum CIPN severity and CIPN pain intensity;
Id. Quality of life;
Ie. Other patient reported outcomes (fatigue and sleep).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (ACUPUNCTURE): Patients receive acupuncture treatment twice per week for week 1 and 2 then once weekly for a total of 14 sessions while undergoing taxane-based chemotherapy throughout the study.
ARM II (CONTROL): Patients undergo at home relaxation exercises while watching 10 minute segments of nature scenery videos for up to 14 sessions throughout the study.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorWeidong Lu